Job Description
Responsibilities:
- Conduct interim monitoring visits (IMVs) and ISF review
- Review electronic medical records (EMR)/patient data
- Source documentation verification (SDV) against case report form data
Desired Qualifications:
- Therapeutic experience in oncology/hematology and cell and gene therapy preferred
- Prior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibility
- Strong working knowledge of FDA and ICH/GCP regulations and guidelines
Personal Qualities:
- Highly detail oriented with special attention to quality and quality control
- Ability to multitask and handle multiple responsibilities simultaneously
- Strong interpersonal skills, including verbal and written communication, are essential
About Orca Bio
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. They maintain a start-up culture of camaraderie and leadership by example, regardless of title.